A Dose-finding Study of ASP4070

NCT03101267 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 4070-CL-0020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to evaluate the efficacy, safety, and dose-response of ASP4070 vaccinated in patients with cedar pollinosis.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Cedar pollinosis; ASP4070; DNA plasmid vaccine

Outcome Measures

Primary Outcomes (1)

• Change From Pre-Exposure in Mean Total 3 Nasal Symptom Score (3TNSS) 120 to 180 Minutes After Start of Cedar Pollen Exposure on Day 183

  Participants were assessed for each symptom (sneezing, nasal discharge and nasal congestion) using the following score every 15 minutes from before cedar pollen exposure until 180 minutes after cedar pollen exposure. 0: None (no symptoms) 1. Mild (symptoms present but easily tolerated) 2. Moderate (awareness of symptoms; bothersome, but tolerable) 3. Severe (definite awareness of symptoms; difficult to tolerate, but does not interfere with the activities of daily living) 4. Very severe (difficult to tolerate and interferes with the activities of daily living). 3TNSS was a summed score of each symptom, and mean of 3TNSS at 120 to 180 min is the average of 5 timepoints of 3TNSS score, which ranged from 0 to 12. Higher 3TNSS score indicated greater disease activity.

  Day 183 at pre-exposure and 120 to 180 minutes after the start of cedar pollen exposure (5 samples 15 minutes apart)

Secondary Outcomes (15)

• Change From Pre-Exposure in Mean Total 4 Nasal Symptom Score (4TNSS) 120 to 180 Minutes After Cedar Pollen Exposure

  Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183

• Change From Pre-Exposure in Sneezing Score 120 to 180 Minutes After Cedar Pollen Exposure

  Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183

• Change From Pre-Exposure in Nasal Discharge Score 120 to 180 Minutes After Cedar Pollen Exposure

  Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183

• Change From Pre-Exposure in Mean Nasal Congestion Score 120 to 180 Minutes After Cedar Pollen Exposure

  Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183

• Change From Pre-Exposure in Mean Itchy Nose Score 120 to 180 Minutes After Cedar Pollen Exposure

  Pre-exposure and 120-180 minutes after the start of pollen exposure (5 samples 15 minutes apart) on Days 127, 155, and 183

Study Arms (3)

ASP4070 4 mg

EXPERIMENTAL

Participants received ASP4070 4 mg 8 times by intradermal vaccination at 14-day intervals.

Drug: ASP4070

ASP4070 1 mg

EXPERIMENTAL

Participants received ASP4070 1 mg 8 times by intradermal vaccination at 14-day intervals.

Drug: ASP4070

Placebo

PLACEBO COMPARATOR

Participants received Placebo 8 times by intradermal vaccination at 14-day intervals.

Drug: Placebo

Interventions

ASP4070 DRUG

Intradermal vaccination at 2-week intervals

ASP4070 1 mg; ASP4070 4 mg

Placebo DRUG

Intradermal vaccination at 2-week intervals

Placebo

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject who has exhibited symptoms of cedar pollinosis, consisting of nasal symptoms (sneezing, nasal discharge or nasal obstruction) and eye symptoms (itchy eyes or watery eyes) during the pollen dispersal seasons in 2016 and 2017
• Subject who is positive for the Japanese red cedar (JRC) pollen-specific serum IgE antibody test
• At screening, subject whose score has worsened compared to baseline over 120 to 180 minutes after cedar pollen exposure in a chamber

You may not qualify if:

• Subject who has positive the test result of serum IgE antibody specific to other antigen than JRC pollen at screening
• Subject who has received specific immunotherapy (including desensitization therapy) for cedar pollinosis in the past
• Subject who has received specific or non-specific immunotherapy within 5 years prior to screening
• Subject who has received laser therapy or surgery for the treatment of nasal symptoms within 3 years prior to screening.
• Subject who has a history of allergic reactions such as anaphylactic shock and exanthema generalized caused by food and/or medical products in the past
• Subject who has a positive test result for hepatitis B surface (HBs) antigen or anti-hepatitis C virus (HCV) antibody
• Subject who has nasal disease that may interfere with the evaluation
• Subject who has autoimmune disease or other serious primary disease
• Subject who was diagnosed with immunodeficiency in the past
• Subject who has a complication of seasonal allergic rhinitis (due to allergens other than Japanese cedars or cypress), perennial allergic rhinitis, rhinitis medicamentosa, or non-allergic rhinitis that requires medical treatment
• Subject who has a complication of cardiovascular disease
• Subject who has a complication of hepatic disease
• Subject who has a complication of renal disease
• Subject who has a complication of respiratory disease
• Subject has a complication of malignant tumor or has been diagnosed with or has received treatment for malignant tumor within 5 years prior to the first vaccination of the study drug

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Immunomic Therapeutics, Inc.: collaborator

Study Sites (1)

Site JP00001

Shinjuku, Tokyo, Japan

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Astellas Pharma Inc.

astellas.resultsdisclosure@astellas.com

+81-3-3244-6500 Japanese only

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2017
• First Posted: April 5, 2017
• Study Start: April 13, 2017
• Primary Completion: January 26, 2018
• Study Completion: October 27, 2018
• Last Updated: November 26, 2024
• Results First Posted: June 30, 2020

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

JP (1)